FDA.report

Ambler Surgical

Primary DI
00190660155087
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Stille-Luer rat tooth rongeur
Catalog number
75-840
Device description
Stille-Luer rat tooth rongeur, 8'', straight, 8.0mm x 10.0mm bite, with teeth
Published
2021-01-07
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
00190660155087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660155087001906601550871906601550870190660155087

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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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