FDA UDI
In Commercial Distribution
🇺🇸 United States
Aspirating Needle
DI: B21232311
·
Model: 32-31
·
INTERNATIONAL MEDICAL INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Aspirating Needle
- Primary DI
- B21232311
- Version / Model
- 32-31
- Catalog Number
- 32-31
- Company Name
- INTERNATIONAL MEDICAL INDUSTRIES INC.
- Labeler DUNS
- 053469565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- 238d0109-77d4-4b72-90ad-84f6d1b3b084
Device Description
16 Gauge x 5" Aspirating Needle, W/ Blunt Cannula. Sterile & Non-Pyrogenic, Individually Blister Packed, Box of 100
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
- 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 |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16627 | Medication transfer needle, non-filtering/non-vented | A slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B21232312 | HIBCC | Box | 100 | In Commercial Distribution | |
| Primary | B21232311 | HIBCC |