SUTUMED SDAG060QE080
GUDID 07757093038375
POLYGLACTIN
Unilene S.A.C.
Polyester suture, bioabsorbable, multifilament Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial| Primary Device ID | 07757093038375 |
| NIH Device Record Key | 47c20d51-7eb5-4941-9c1d-589143cddc71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUTUMED |
| Version Model Number | SDAG060QE080 |
| Catalog Number | SDAG060QE080 |
| Company DUNS | 934900072 |
| Company Name | Unilene S.A.C. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com |
Device Dimensions
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 80 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Temperature | Between 19 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07757093002956 [Primary] |
| GS1 | 07757093038375 [Package] Contains: 07757093002956 Package: BOX [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100780
FDA Product Code
| GAN | SUTURE, ABSORBABLE, SYNTHETIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
[07757093038375]
Dry Heat Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-22 |
| Device Publish Date | 2019-11-14 |
On-Brand Devices [SUTUMED]
Trademark Results [SUTUMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUTUMED 87158058 not registered Dead/Abandoned |
SUTUMED CORP. 2016-09-01 |
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