FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium UNIFY Fast Plain Gut Sutures
DI: 00814639026214
·
Model: PSRJ-518R13
·
APPLIED DENTAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Premium UNIFY Fast Plain Gut Sutures
- Primary DI
- 00814639026214
- Version / Model
- PSRJ-518R13
- Catalog Number
- PSRJ-518R13
- Company Name
- APPLIED DENTAL, INC.
- Labeler DUNS
- 017524666
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-21
- Public Version
- 2
- Public Version Date
- 2024-10-18
- Public Version Status
- Update
- Public Device Record Key
- 72d0dd71-5cd0-4f65-8524-17aec9e7624b
Device Description
Premium UNIFY Fast Absorbing Gut Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | 878.4830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13898 | Catgut suture, plain | A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10814639026211 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00814639026214 | GS1 | ||||
| Package | 20814639026218 | GS1 | Case | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-888-841-8481
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000542 | 000 |