FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10888277393141
·
Model: 3302GRH
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10888277393141
- Version / Model
- 3302GRH
- Catalog Number
- 3302GRH
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-09
- Public Version
- 1
- Public Version Date
- 2023-10-17
- Public Version Status
- New
- Public Device Record Key
- d449e911-8ecf-48fd-855d-78f40efe45ab
Device Description
3302G @LONE STAR RETRACTOR RING STERILE
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
- 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 |
|---|---|---|---|---|
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47431 | Radial surgical retractor | A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and internal fixed or retracting ring interconnected with an elastomeric sleeve/sheath intended to also provide protection against wound contamination, and may include channels/tubing to allow wound-edge irrigation. Also known as a lap disc, hand access device, handport, or protector, it may be used with or without a seal cap for colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device. | No | Active |
| 47821 | Surgical retractor/retraction system blade, single-use | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888277393141 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]