FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660214722
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Bookwalter-Style Richardson retractor
Catalog number
70-797
Device description
Bookwalter-Style Richardson retractor, 7 5/8'', 3/4'' x 1'' blade
Published
2021-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071771000INSTRUMED RETRACTORSInstrumed International, Inc.2007-08-02GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660214722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660214722001906602147221906602147220190660214722

GMDN Terms#

Term, Definition table
TermDefinition
Upper-limb traction wrap/trap, reusableA preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of metal or synthetic polymer materials (e.g., nylon) with self-retaining fasteners (e.g., Velcro), and may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame; some types may be inflatable to provide grip by means of air pressure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

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Primary DI, Brand, Company table
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00724995355340V. MuellerSteris CorporationGZT2026-08-18
00724995355364V. MuellerSteris CorporationGZT2026-08-18
00724995355388V. MuellerSteris CorporationGZT2026-08-18
00190776408756MillenniumAvalign Technologies, Inc.GZT2026-08-03
00190776402167MillenniumAvalign Technologies, Inc.GZT2026-07-21
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
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00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
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