FDA UDI
In Commercial Distribution
🇺🇸 United States
Susol® Skin Hook Gillies Fine Large 15cm (Pack of 10)
DI: 05060418834357
·
Model: SS26-2501
·
BAILEY INSTRUMENTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Susol® Skin Hook Gillies Fine Large 15cm (Pack of 10)
- Primary DI
- 05060418834357
- Version / Model
- SS26-2501
- Company Name
- BAILEY INSTRUMENTS LTD
- Labeler DUNS
- 769260357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-23
- Public Version
- 1
- Public Version Date
- 2024-01-31
- Public Version Status
- New
- Public Device Record Key
- c7357859-e090-4594-86d4-09c3f6e3da01
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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64022 | Soft-tissue surgical hook, single-use | A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060418833039 | GS1 | Pack | 10 | In Commercial Distribution | |
| Primary | 05060418834357 | GS1 |