SUTUMED
GUDID 07757093060000
Unilene S.A.C.
Polyolefin/fluoropolymer suture, monofilament| Primary Device ID | 07757093060000 |
| NIH Device Record Key | 3680eda6-e831-4967-8bae-dc8d4fbe9943 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUTUMED |
| Version Model Number | SDPP030MC260 |
| Company DUNS | 934900072 |
| Company Name | Unilene S.A.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| 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 | |
| Phone | +051()997509089 |
| marthalujan@unilene.com | |
| Phone | +051()997509089 |
| marthalujan@unilene.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07757093024583 [Primary] |
| GS1 | 07757093060000 [Package] Contains: 07757093024583 Package: BOX [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123034
FDA Product Code
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-02 |
| Device Publish Date | 2023-01-07 |
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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