FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403075056
Brand
V. Mueller
Company
STERIS CORPORATION
Model
NL3785-251
Catalog number
NL3785251
Device description
V. Mueller RHOTON MALLEABLE STEEL RETRACTOR WITH SQUARE END TIPS CENTER 7MM, TIPS 8 and 12MM WIDE OVERALL LENGTH 8-1/4 inches 21CM
Published
2016-09-24
Public version status
Update
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
K895395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895395000V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTORBaxter Healthcare Corp1989-10-19GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403075056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540307505610885403075056

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)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995237059V. MuellerCD75CCD75C2026-09-24
00724995237066V. MuellerCD75CBLACKCD75CBLACK2026-09-24
00724995237073V. MuellerCD75CBLUECD75CBLUE2026-09-24
00724995237080V. MuellerCD75CGOLDCD75CGOLD2026-09-24
00724995237097V. MuellerCD75CGREENCD75CGREEN2026-09-24
00724995237103V. MuellerCD75CPURPLECD75CPURPLE2026-09-24
00724995237110V. MuellerCD75CREDCD75CRED2026-09-24
00724995237127V. MuellerCD76BCD76B2026-09-24
00724995237134V. MuellerCD76BBLACKCD76BBLACK2026-09-24
00724995237141V. MuellerCD76BBLUECD76BBLUE2026-09-24
00724995237158V. MuellerCD76BGOLDCD76BGOLD2026-09-24
00724995237165V. MuellerCD76BGREENCD76BGREEN2026-09-24
00724995237172V. MuellerCD76BPURPLECD76BPURPLE2026-09-24
00724995237189V. MuellerCD76BREDCD76BRED2026-09-24
00724995237196V. MuellerCD76CCD76C2026-09-24
00724995237202V. MuellerCD76CBLACKCD76CBLACK2026-09-24
00724995237219V. MuellerCD76CBLUECD76CBLUE2026-09-24
00724995237226V. MuellerCD76CGOLDCD76CGOLD2026-09-24
00724995237233V. MuellerCD76CGREENCD76CGREEN2026-09-24
00724995237240V. MuellerCD76CPURPLECD76CPURPLE2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776420406MillenniumAvalign Technologies, Inc.GZT2026-08-26
00190776417239MillenniumAvalign Technologies, Inc.GZT2026-08-19
00190776416997MillenniumAvalign Technologies, Inc.GZT2026-08-18
00724995355296V. MuellerSteris CorporationGZT2026-08-18
00724995355319V. MuellerSteris CorporationGZT2026-08-18
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
10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537588Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537670TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537694TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537717TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537724TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537748TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537779Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537816TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
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10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
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10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23