FDA UDI
In Commercial Distribution
🇺🇸 United States
POLYGLYTONE 6211
DI: 34026704603900
·
Model: IPN000862
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- POLYGLYTONE 6211
- Primary DI
- 34026704603900
- Version / Model
- IPN000862
- Catalog Number
- 833-135
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-15
- Public Version
- 2
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 814c3b48-2fd3-47fd-a104-3db49f72c465
Device Description
Polyglytone 6211 Size 2-0 36" CST-43 Needle T Needle BSC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | General, Plastic Surgery | 878.4493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57991 | Polyglytone suture | A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polyglytone 6211 (a polyester composed of glycolide, caprolactone, trimethylene carbonate, and lactide) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues, including use in ophthalmic surgery but not for cardiovascular/neurological surgery and microsurgery; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14026704603906 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 34026704603900 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042141 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Suture Length 36", Needle 1 Length 1.030", Needle 2 Length 0.156" |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature