FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Medical Specialties, Inc.
DI: 00815849021952
·
Model: CMS-631-SC
·
CUSTOM ASSEMBLIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Custom Medical Specialties, Inc.
- Primary DI
- 00815849021952
- Version / Model
- CMS-631-SC
- Company Name
- CUSTOM ASSEMBLIES, INC.
- Labeler DUNS
- 948904735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f682e10f-7ab3-49aa-8562-ea760331e503
Device Description
9.5" Serrated Sponge Forcep - Sterile
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47570 | Utility forceps, single-use | A sterile, hand-held, manual surgical instrument designed for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel or plastic material. It is available in various sizes and the working end will typically have grasping blades that are elongated or shaped as large oval or triangular rings. The blades are usually serrated to enhance grip on the objects being picked up. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00815849021969 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00815849021952 | GS1 |