FDA UDI
In Commercial Distribution
🇺🇸 United States
2hr18 3-0 U Mnd 16x16 13mm Ldr
DI: 00848782019366
·
Model: RS-1001Q
·
Surgical Specialties México, S. de R.L. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- 2hr18 3-0 U Mnd 16x16 13mm Ldr
- Primary DI
- 00848782019366
- Version / Model
- RS-1001Q
- Company Name
- Surgical Specialties México, S. de R.L. de C.V.
- Labeler DUNS
- 812762226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-22
- Public Version
- 5
- Public Version Date
- 2024-12-25
- Public Version Status
- Update
- Public Device Record Key
- 267ce94e-d95a-46ac-924f-8a829ddc7e2b
Device Description
2hr18 3-0 U Mnd 16x16 13mm Ldr
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | General, Plastic Surgery | 878.4493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60480 | Barbed polyester suture, non-antimicrobial | A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848782019363 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00848782019366 | GS1 |
Customer Contacts
- Phone
- +1(877)991-1110
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3-0 USP |