FDA.reportPublic FDA data

SCOPE HOLDER ARM

Primary DI
00888118009012
Brand
SCOPE HOLDER ARM
Company
KLS-Martin L.P.
Model
07-001-42-07
Device description
ARMAND, COMPLETE W/OUT TABLE CLAMP, STANDARD
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118009012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118009012008881180090128881180090120888118009012

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118132529LEVEL ONE EXTREMITY26-627-12-912026-04-23
00888118036582_LEVEL ONE CMF25-043-16-092016-03-24
00888118048196LEVEL ONE CMF25-885-05-912016-03-24
00888118073471LEVEL ONE CMF50-173-01-092016-03-24
00888118073488LEVEL ONE CMF50-173-02-092016-03-24
00888118075581DISTRACTION, INTERNAL50-347-05-092016-03-24
00888118075604DISTRACTION, INTERNAL50-347-07-092016-03-24
00888118075611DISTRACTION, INTERNAL50-347-09-092016-03-24
00888118075635DISTRACTION, INTERNAL50-348-05-092016-03-24
00888118075659DISTRACTION, INTERNAL50-348-07-092016-03-24
00888118075666DISTRACTION, INTERNAL50-348-09-092016-03-24
00888118104007DISTRACTION, INTERNAL, STERILE50-347-05-712016-12-16
00888118104014DISTRACTION, INTERNAL, STERILE50-347-07-712016-12-16
00888118104021DISTRACTION, INTERNAL, STERILE50-347-09-712016-12-16
00888118104038DISTRACTION, INTERNAL, STERILE50-348-05-712016-12-16
00888118104045DISTRACTION, INTERNAL, STERILE50-348-07-712016-12-16
00888118104052DISTRACTION, INTERNAL, STERILE50-348-09-712016-12-16
00888118112682LEVEL ONE CMF25-885-05-612018-01-26
00888118113399DISTRACTION, INTERNAL50-347-05-612018-01-26
00888118113405DISTRACTION, INTERNAL50-347-07-612018-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30