| Primary Device ID | M24835391011 |
| NIH Device Record Key | 2de27004-ec34-4807-b25c-46ef747426db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® Padgett® Dermatomes |
| Version Model Number | 3539101 |
| Catalog Number | 3539101 |
| Company DUNS | 963856096 |
| Company Name | INTEGRA LIFESCIENCES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780277835 [Primary] |
| HIBCC | M24835391011 [Secondary] |
| GFD | DERMATOME |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
[M24835391011]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-06-22 |
| Device Publish Date | 2018-02-23 |
| M24835396001 | Model PI (120V) - Dermatome Complete Kit - USA/Canada Only |
| M24835392501 | Model B (120V) - Dermatome Complete Kit - USA/Canada Only |
| M24835396002301 | Model PI (230V) - Dermatome Complete Kit |
| M24835392502301 | Model B (230V) - Dermatome Complete Kit |
| M2483539100TA1 | Kit, Manual Dermatome, Medium (4") |
| M2483539100BTA1 | Kit, Manual Dermatome, Small (3") |
| M24835391005TA1 | Kit, Manual Dermatome, large (5") |
| M24835395001 | Model C - Air Dermatome Complete Kit |
| M24835399001 | Model S6 Slimline Dermatome Complete Unit |
| M24835397001 | Model S Slimline Dermatome Complete Unit |
| M248DP08101 | Hand piece, SB Model - USA/Canada Only |
| M24835398001 | Model SB Slimline Dermatome Complete Unit - USA/Canada Only |
| M24835396021 | Blade, Dermatome (For Models S6 and PI)(6 languages) |
| M24835392521 | Blade, Dermatome (For Models S, SB, B and C)(6 languages) |
| M24835391061 | Blade, Dermatome (For Manual Models, Baby Size)(6 languages) |
| M24835391051 | Blade, Dermatome (For Manual Models, Regular Size)(6 languages) |
| M248P1731 | Roller and Handle (complete, for P170) |
| M248P1721 | Teflon Roller for Skin Graft Expander |
| M248P1701 | Mesh Skin Graft Expander, 4.25" x 5.50" |
| M2483539118R1 | Clip, Replacement: Blade Clip for 4 and 5" Drum |
| M2483539118B1 | Clip, Replacement: Blade Clip for 3" Drum |
| M248353910151 | Five inch Manual Dermatome (Drum and Stand Only), 5X8 Inch Size. (12.5 X 20 cm)(Large) |
| M24835391181 | Screws for 3539118B and 3539118R |
| M24835391171 | Thickness Gauge |
| M24835391151 | Storage or carrying case |
| M24835391021 | Three inch Manual Dermatome (Drum & Stand) 3X8 Inch Size. (7.5 X 20 cm)(Small) |
| M24835391011 | Four inch Manual Dermatome (Drum & Stand) 4X8 Inch Size. (10X20 cm)(Medium) |
| M248DP00101 | Dermatome Hand piece, Model S6 |
| M248DP00091 | Dermatome Hand piece, Model S |
| M248DP00031 | Hand piece, PI Model |
| M248DP00011 | Hand piece, B Model |
| M248AP11841 | Air Male Guard, Model C |
| M248AP03551 | Green Gasket |
| M248AP00011 | Hand piece, Model C (Air)+C2 |
| M2483539715251 | 25' (7.62 m) Hand piece power cord |
| M2483539715131 | 13' (3.96 m) Hand piece power cord |
| M248353991061 | 6" (15.2 cm) Width blade clip |
| M248353991051 | 5" (12.7 cm) Width blade clip |
| M248353991041 | 4" (10.16 cm) Width blade clip |
| M248353991031 | 3" (7.62 cm) Width blade clip |
| M248353991021 | 2" (5.08 cm) Width blade clip |
| M248353991011 | 1" (2.54 cm) Width blade clip |
| M248353991001 | Guard Plate, Dermatome Head Assy |
| M248353961061 | 6" Width blade clamp (15.24 cm) |
| M248353961051 | 5" Width blade clamp (12.70 cm) |
| M248353961041 | 4" Width blade clamp (10.16 cm) |
| M248353961031 | 3" Width blade clamp (7.62 cm) |
| M248353961021 | 2" Width blade clamp (5.08 cm) |
| M248353961011 | 1" Width blade clamp (2.54 cm) |
| M248353961001 | Guard Plate, Dermatome Head Assy |