FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10888277390454
·
Model: AR8704R
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10888277390454
- Version / Model
- AR8704R
- Catalog Number
- AR8704R
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-21
- Public Version
- 1
- Public Version Date
- 2025-03-03
- Public Version Status
- New
- Public Device Record Key
- e8b08dec-0d75-482c-9b59-c775de2a3230
Device Description
AR-8704 MICRO SUTLASSO,TFCC,SHRT 70 B
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 |
|---|---|---|---|---|
| HWQ | PASSER | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61823 | Suturing unit, reprocessed | A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888277390451 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 10888277390454 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]