FDA UDI
In Commercial Distribution
🇺🇸 United States
POLYESTER TAPE
DI: 00384401513124
·
Model: Size 4.8mm x 76.2cm (3/16 in x 30 in)
·
INTERVASCULAR SAS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- POLYESTER TAPE
- Primary DI
- 00384401513124
- Version / Model
- Size 4.8mm x 76.2cm (3/16 in x 30 in)
- Company Name
- INTERVASCULAR SAS
- Labeler DUNS
- 382174019
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-16
- Public Version
- 3
- Public Version Date
- 2019-09-10
- Public Version Status
- Update
- Public Device Record Key
- 6a7ca3e0-e7cc-4d88-afdd-ad3cc755b8d5
Device Description
Polyester Tape size 4.8mm x 76.2cm (3/16 in x 30 in) are commercially available only in multipack configuration (1 pair per pouch / 5 pouches per box) with the catalog number M002000194131.
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46242 | Surgical support tape, non-bioabsorbable | A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00384401513216 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00384401513124 | GS1 |
Customer Contacts
- Phone
- +33442084646
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at controlled room temperature