FDA.reportPublic FDA data

V. Mueller

Primary DI
10724995233386
Brand
V. Mueller
Company
Steris Corporation
Model
AH21
Catalog number
AH21
Device description
V. Mueller STERRAD ARROWS
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012931000
K153554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012931000GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEMAllegiance Healthcare Corp.2002-08-20FRG
K153554000Genesis Low Temperature Reusable Rigid Container SystemCarefusion 2200, Inc.2016-03-21KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403159937PreviousGS10
10724995233386PrimaryGS10
00724995233389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088540315993720885403159937
1072499523338610724995233386
00724995233389007249952333897249952333890724995233389

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, single-useA label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed as a locking tag. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
149891242
Device count
150
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995248444Snowden-Pencer886118V886118V2026-10-27
00724995248451Snowden-Pencer886122V886122V2026-10-27
00724995248468Snowden-Pencer886127V886127V2026-10-27
10885403035562V. MuellerCH8680CH86802020-04-15
10885403035579V. MuellerCH8680-001CH86800012020-04-15
10885403035586V. MuellerCH8681CH86812020-04-15
10885403022470V. MuellerRH600RH6002018-09-14
10885403092084V. MuellerOP0907-601OP09076012018-09-05
10885403092091V. MuellerOP0907-602OP09076022018-09-05
10885403099120V. MuellerOP5000OP50002018-09-07
10885403099137V. MuellerOP5005OP50052018-09-07
10885403099144V. MuellerOP5500OP55002018-09-07
10885403099182V. MuellerOP5505OP55052018-09-07
10885403099199V. MuellerOP5510OP55102018-09-07
10885403099205V. MuellerOP5520OP55202018-09-07
10885403099625V. MuellerOP5666OP56662019-01-02
10885403099717V. MuellerOP5700OP57002019-01-02
10885403099779V. MuellerOP5760OP57602019-01-02
10885403099786V. MuellerOP5761OP57612019-01-02
10885403104909V. MuellerOS4610OS46102018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006765Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006772Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006789Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006796Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006802Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006819Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006826Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006833Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006840Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006857Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006864Mastel SurgicalMastel Surgical Inc.KCT2026-10-23