FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EMERGE MEDICAL & Design
DI: 00886020028985
·
Model: 399.97.EM
·
EMERGE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EMERGE MEDICAL & Design
- Primary DI
- 00886020028985
- Version / Model
- 399.97.EM
- Catalog Number
- 399.97.EM
- Company Name
- EMERGE MEDICAL, INC.
- Labeler DUNS
- 078642955
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-08
- Public Version
- 5
- Public Version Date
- 2018-06-11
- Public Version Status
- Update
- Public Device Record Key
- 38e1426b-b6da-4c22-ba53-fe1a33eeb3e2
- Distribution End Date
- 2018-05-01
Device Description
REDUCTION FORCEPS WITH POINTS RATCHET, 130MM LENGTH
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42894 | Implant handling forceps, scissors-like | A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886020028985 | GS1 |