FDA UDI
In Commercial Distribution
🇺🇸 United States
ReliaTack
DI: 10884521726376
·
Model: RELTACK3X10SW
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ReliaTack
- Primary DI
- 10884521726376
- Version / Model
- RELTACK3X10SW
- Catalog Number
- RELTACK3X10SW
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- a3359747-f038-41fe-b06c-8ae2cdc94273
Device Description
Articulating Reloadable Fixation Device
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GDW | STAPLE, IMPLANTABLE | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59874 | Endoscopic manual linear stapler | A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30884521726370 | GS1 | PACK_OR_INNER_PACK | 3 | In Commercial Distribution | |
| Primary | 10884521726376 | GS1 | ||||
| Package | 20884521726373 | GS1 | CASE | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140609 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;