FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403014635
Brand
V. Mueller
Company
STERIS CORPORATION
Model
BE400
Catalog number
BE400
Device description
V. Mueller JACKSON TRACHEAL RETRACTOR FLAT BLADE 1.3CM WIDE ON 1 END 2 PRONGS ON OTHER END OVERALL LENGTH 7 inches 17.8CM
Published
2018-08-02
Public version status
Update
Distribution status
Not 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
KALRETRACTOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403014635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540301463510885403014635

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)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
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
00724995220228NAArm SupportBF4312024-01-31
00724995225148NABF00066BF000662025-03-31
00724995217280NAPowerLift PlusBF8672022-12-20
00724995225155NABF686BF6862024-04-08
10885403097836V. MuellerOP2610OP26102018-09-07
10885403099878V. MuellerOP6581OP65812019-01-02
10885403099939V. MuellerOP6975OP69752018-09-07
10885403099960V. MuellerOP6990OP69902018-09-07
10885403105395V. MuellerOS5500OS55002018-09-10
10885403111792V. MuellerRH751RH7512018-09-14
10885403112102V. MuellerRH1045RH10452018-09-10
10885403072833V. MuellerNL2750NL27502018-08-30
10885403073090V. MuellerNL3106NL31062018-08-30
10885403073113V. MuellerNL3108NL31082018-08-30
10885403113628V. MuellerRH1830RH18302018-09-10
10885403113635V. MuellerRH1860RH18602018-09-10
10885403026348V. MuellerCH2605CH26052018-08-09
00724995225117NALeg PositionerBF3512023-10-03
10885403008566V. MuellerAU5685AU56852022-11-27
10885403096846V. MuellerOP1500-002OP15000022022-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432607MillenniumAvalign Technologies, Inc.KAL2026-09-28
00724995327408V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00724995327422V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00841536148602ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148619ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148626ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148633ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00190776429065MillenniumAvalign Technologies, Inc.KAL2026-09-04
04054462156498evonosevonos GmbH & Co. KGKAL2026-08-26
04054462156504evonosevonos GmbH & Co. KGKAL2026-08-26
04054462913039evonosevonos GmbH & Co. KGKAL2026-08-26
00190776417253MillenniumAvalign Technologies, Inc.KAL2026-08-19
00190776417710MillenniumAvalign Technologies, Inc.KAL2026-08-19
04054462913060evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913077evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913091evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913107evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913114evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913121evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913138evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913145evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913169evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913213evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913237evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913251evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913275evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913152evonosevonos GmbH & Co. KGKAL2026-08-18
04054462915828evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915835evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915842evonosevonos GmbH & Co. KGKAL2026-08-17