FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE RENEWAL
DI: 10888277368309
·
Model: 173016R
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE RENEWAL
- Primary DI
- 10888277368309
- Version / Model
- 173016R
- Catalog Number
- 173016R
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-29
- Public Version
- 1
- Public Version Date
- 2025-02-06
- Public Version Status
- New
- Public Device Record Key
- 0d69eb12-4287-4375-86e8-d4ee255cabde
Device Description
173016 @ENDO STITCH 10 MM SUTURING D
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 |
|---|---|---|---|---|
| HCF | INSTRUMENT, LIGATURE PASSING AND KNOT TYING | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59869 | Endoscopic manual linear cutting stapler, reprocessed | A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery, for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
| 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 | 20888277368306 | GS1 | CS | 3 | In Commercial Distribution | |
| Primary | 10888277368309 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]