FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660155971
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Ruler
Catalog number
44-715
Device description
Ruler, 20'', measurements in inches and millimeters, flexible
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660155971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660155971001906601559711906601559710190660155971

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). 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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154255LEVEL ONE EXTREMITYKLS-Martin L.P.FTY2026-05-25
00810180843331Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
08806373887703BENCOX Surgical InstrumentsCorentec Co., LtdFTY2026-02-23
00842071152963AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
B382SD2644404000Surgical DirectSurgical Direct, Inc.FTY2026-02-16
00757770421848Bausch + LombBausch & Lomb IncorporatedFTY2026-02-11
03662663108072Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
03662663108089Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
B382SD91328410000Surgical DirectSurgical Direct, Inc.FTY2026-02-10
08681506801500SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-02-09
08681506801593ScharfSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-01-31
00847538005479Patella CaliperSYMMETRY MEDICAL INC.FTY2025-12-10
09348811038784INKAThe Trustee for KAISER FAMILY TRUSTFTY2025-12-02
00810207782599Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDFTY2025-11-24
00887868287503Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-14
04719846016576CharderCHARDER ELECTRONIC CO., LTD.FTY2025-11-13
00763000684044Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FTY2025-09-21
B382SD1327110040Surgical DirectSurgical Direct, Inc.FTY2025-09-09
04059453050144Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-08-25
00757770405237Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413102Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770450831Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770676309Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413843Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770422531Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770669615Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
20197344154651MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
00190776406899MillenniumAvalign Technologies, Inc.FTY2025-07-25
04059453186676Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-07-23
B382SD1325910000Surgical DirectSurgical Direct, Inc.FTY2025-07-23