FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653031221
Brand
AESCULAP
Company
Aesculap AG
Model
BT492R
Catalog number
BT492R
Device description
"KOCHER-WAGNER Retractor, 11"", (280 mm), depth: 36 mm, width: 20 mm, non-sterile, reusable"
Published
2020-04-17
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653031221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653031221040386530312214038653031221

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24
04038653201563NOVOCARTFR686RFR686R2020-04-23
04038653403912NOVOCARTFR721RFR721R2020-04-23
04038653403929NOVOCARTFR722RFR722R2020-04-23
04038653403936NOVOCARTFR723RFR723R2020-04-23
04038653403943NOVOCARTFR724RFR724R2020-04-23
04038653403950NOVOCART 3DFR725RFR725R2020-04-23
04038653403967NOVOCARTFR726RFR726R2020-04-23
04038653403974NOVOCARTFR727RFR727R2020-04-23
04038653422357NOVOCARTFR730RFR730R2020-04-23
04038653422388NOVOCARTFR731RFR731R2020-04-23
04046963315498NOVOCARTFR737RFR737R2020-04-23
04046963315504NOVOCARTFR738RFR738R2020-04-23
04046963315511NOVOCARTFR739RFR739R2020-04-23
04046963315528NOVOCARTFR740RFR740R2020-04-23
04038653201556NOVOCARTFR685RFR685R2020-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09
00888937033663ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
00192896123540Green RetractorSONTEC INSTRUMENTS, INC.GAD2026-06-24
00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
00348783011456Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
00348783011463Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
008401944956533P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956843P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
05060212055323Silicone Bands 2.16mm x 110mm dia x 3DTR MEDICAL LIMITEDGAD2026-06-10
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04