FDA.reportPublic FDA data

MEDLINE

Primary DI
30197344029680
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DEB001
Catalog number
DEB001
Device description
DEBRIDEMENT TOOL, DIGITOUCH
Published
2024-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEDBRUSH, DERMABRASION, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEDBrush, Dermabrasion, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344029683PackageGS125In Commercial Distribution
30197344029680PackageGS16In Commercial Distribution
10197344029686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734402968320197344029683
3019734402968030197344029680
1019734402968610197344029686

GMDN Terms#

Term, Definition table
TermDefinition
Manual wound debridement toolA device intended to be used for the manual debridement of wounds (e.g., diabetic foot ulcers, venous ulcers, arterial ulcers, pressure ulcers, bedsores) by gentle wiping of the wound surface to remove unhealthy tissue (e.g., exudate, slough, cellular debris) to promote healing. It is available in a variety of forms (e.g., a swab-like pad with a handle, a thimble-like device worn on the end of a finger); the surface used for debridement is typically made of synthetic polymer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344029686MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
00630094188256Bioseal Inc.BIOSEALGED2023-10-05
00630094188263Bioseal Inc.BIOSEALGED2023-10-05
00630094188300Bioseal Inc.BIOSEALGED2023-10-05
00630094188409Bioseal Inc.BIOSEALGED2023-10-05
00630094188706Bioseal Inc.BIOSEALGED2023-10-05
00630094188904Bioseal Inc.BIOSEALGED2023-10-05
00630094188911Bioseal Inc.BIOSEALGED2023-10-05
00630094188928Bioseal Inc.BIOSEALGED2023-10-05
00630094188935Bioseal Inc.BIOSEALGED2023-10-05
10630094188253Bioseal Inc.BIOSEALGED2023-10-05
10630094188260Bioseal Inc.BIOSEALGED2023-10-05
10630094188307Bioseal Inc.BIOSEALGED2023-10-05
10630094188406Bioseal Inc.BIOSEALGED2023-10-05
10630094188703Bioseal Inc.BIOSEALGED2023-10-05
10630094188901Bioseal Inc.BIOSEALGED2023-10-05
10630094188918Bioseal Inc.BIOSEALGED2023-10-05
10630094188925Bioseal Inc.BIOSEALGED2023-10-05
10630094188932Bioseal Inc.BIOSEALGED2023-10-05
00850019947847Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947878Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947632Dermal Cooling SystemR2 DERMATOLOGY INC.GED2023-06-09
B7687834600Buxton BioMedicalBuxton Biomedical IncGED2023-01-10
00827002485273CookCOOK INCORPORATEDGED2020-10-02
00860371002306Norsen Debrider, SterileBEL-MED, INC.GED2019-05-29