FDA.report

SYRINGE-2CC-LUER-METAL HUB

Primary DI
D9281071490
Brand
SYRINGE-2CC-LUER-METAL HUB
Company
W.H. Holden, Inc.
Model
10-7149
Published
2023-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9281071490PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental anaesthesia syringe, intraligamentaryA hand-held manual dental device designed for injecting an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
183854322
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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