FDA.reportPublic FDA data

Sterilizable Handles

Primary DI
00887761968547
Brand
Sterilizable Handles
Company
Baxter Medical Systems GmbH + Co. KG
Model
4025709
Device description
Sterilizable Camera Handle, 1 pc
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQPLamp, operating-room
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761968547PackageGS13In Commercial Distribution
00887761967267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761968547008877619685478877619685470887761968547
00887761967267008877619672678877619672670887761967267

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, reusableA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4936715860SURGICAL@HILLROM.COM

Regulatory Flags#

DUNS number
330961223
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00887761968479VidiaPort40281552023-01-17
00887761968486VidiaPort40281522023-01-17
00887761968493VidiaPort40281502023-01-17
00887761968509VidiaPort40281402023-01-17
00887761968516VidiaPort40281302023-01-17
00887761979840TRUMPF MEDICAL40281522022-11-29
00887761980105TRUMPF MEDICAL40281402022-11-29
00887761980112TRUMPF MEDICAL40281502022-11-29
00887761980129TRUMPF MEDICAL40281552022-11-29
00887761970007Leg Sections20778652022-12-14
00887761970045Head Sections20778602022-12-14
00887761970052Back Sections20775952022-12-14
00887761970144Pelvis Sections20726292022-12-15
00887761970151Leg Sections20726282022-12-15
00887761970168Leg Sections20726262022-12-15
00887761970175Leg Sections20726252022-12-14
00887761970182Back Sections20726242022-12-14
00887761970199Head Sections20726232022-12-14
00887761970014Leg Sections20778642022-12-14
00887761970069Back Sections20775942022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
14714127861392AESCULAPAesculap AGKQM2023-11-05
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761967267Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGKQM2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-06-26
30845854050730CONMEDConmed CorporationKQM2023-06-16
10618125131041DEXcam3™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
10618125155870DEXcam4™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968288iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968400TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968417TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968134Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15
00887761968301iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2022-12-15
00887761979840TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFQP2022-11-29
00887761980129TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFQP2022-11-29
00836230002008C-Arm Cover UNIVERSAL 112/183PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.KQM2022-11-18
00836230002015C-Arm Cover IMAGE INTENSHFIER 115/240PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.KQM2022-11-18
00836230002053C-Arm Cover 152/265PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.KQM2022-11-18
00836230002121Mini C-Arm Cover & X-Ray Drape 138/160PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.KQM2022-11-18