FDA.report

C-CAM

Primary DI
04048551276891
Brand
C-CAM
Company
Karl Storz GmbH & Co. KG
Model
20290131
Device description
C-CAM Camera Head, 6-pin
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551276891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551276891040485512768914048551276891

GMDN Terms

TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods

Method
Ethylene Oxide;Hydrogen Peroxide

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417888MillenniumAvalign Technologies, Inc.GCJ2026-03-11
B382SD4387110Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD481753PTSTR0Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817570Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817590Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
00198506088964ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089060ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089077ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089084ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
B382SD56534910Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD56740240Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD76500310Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
04251303824985BLUEENDOTROKAMED GmbHGCJ2026-02-27
00198506088704ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088711ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088216ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088483ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088490ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23