FDA.report

Ambler Surgical

Primary DI
00190660142018
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Sims vaginal retractor
Catalog number
73-203
Device description
Sims vaginal retractor, 6 5/8'', double-ended, 3'' deep x 1'' wide and 3 1/4'' deep x 1 1/4'' wide blades, concave handle
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
HDLRETRACTOR, VAGINAL

Product Code Classifications

CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660142018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660142018001906601420181906601420180190660142018

GMDN Terms

TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089039ELMED INCORPORATEDELMED INCORPORATEDHDL2026-03-03
00198506089046ELMED INCORPORATEDELMED INCORPORATEDHDL2026-03-03
00198506088797ELMED INCORPORATEDELMED INCORPORATEDHDL2026-02-25
00198506088827ELMED INCORPORATEDELMED INCORPORATEDHDL2026-02-25
00198506087240ELMED INCORPORATEDELMED INCORPORATEDHDL2025-12-18
00190776409364MillenniumAvalign Technologies, Inc.HDL2025-08-28
00190776414535MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414542MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414566MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414580MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414597MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414603MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414627MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414634MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414641MillenniumAvalign Technologies, Inc.HDL2025-08-15
00194613033224MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00194613065737MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00194613117894MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00194613124205MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00190776406677MillenniumAvalign Technologies, Inc.HDL2025-07-23
00190776394622MillenniumAvalign Technologies, Inc.HDL2025-05-07
00190776394639MillenniumAvalign Technologies, Inc.HDL2025-05-07
00190776392680MillenniumAvalign Technologies, Inc.HDL2025-05-02
00194613065355MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-03-21
00198506081163ELMED INCORPORATEDELMED INCORPORATEDHDL2025-03-12
00198506081170ELMED INCORPORATEDELMED INCORPORATEDHDL2025-03-12
00198506075360ELMED INCORPORATEDELMED INCORPORATEDHDL2025-02-18
00850071684254Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDL2025-01-21
00198506074462ELMED INCORPORATEDELMED INCORPORATEDHDL2025-01-20
00198506074479ELMED INCORPORTEDELMED INCORPORATEDHDL2025-01-20