FDA.report

Ambler Surgical

Primary DI
00190660067571
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Oral surgery exodontia extraction forceps
Catalog number
32-704
Device description
Oral surgery exodontia extraction forceps, 6'', #151S, lower, squeeze handle
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660067571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660067571001906600675711906600675710190660067571

GMDN Terms

TermDefinition
Tooth extraction forcepsA hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
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
false
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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