FDA.reportPublic FDA data

HEINE SIGMA®250

Primary DI
04053755126347
Brand
HEINE SIGMA®250
Company
Heine Optotechnik GmbH & Co. KG
Model
000
Catalog number
E-003.18.100
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCMEndoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755126347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755126347040537551263474053755126347

GMDN Terms#

Term, Definition table
TermDefinition
Rigid sigmoidoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (603) 742-7103service@heine-na.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203321DELTA X CPP00K-000.34.2372025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755203031BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755202973FINOFF TRANSILLUMINATOR2,5 VC-001.17.0802025-07-17
04053755202966BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755203048GAMMA 3.2000M-000.09.9472025-07-17
04053755202928DELTAoneBLACK WHITE EDITIONK-214.28.3052025-04-30
04053755136988GAMMA 3.1000M-000.09.9412022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506002311ELMEDELMED INCORPORATEDGCM2024-04-24
00842180187597ELMEDELMED INCORPORATEDGCM2024-04-09
00842180185685ELMEDELMED INCORPORATEDGCM2024-02-20
04053755125999DOUBLE INSUFFLATION BULBHeine Optotechnik GmbH & Co. KGGCM2022-12-12
04055207062890PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062906PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062913PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062920PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062937PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062944PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04042761083485OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04953170393112DVI CABLE 3MOLYMPUS MEDICAL SYSTEMS CORP.GCM2020-05-27
04055207065761NARichard Wolf GmbHGCM2020-05-06
00842180136014ELMEDELMED INCORPORATEDGCM2019-04-30
00842180135970ELMEDELMED INCORPORATEDGCM2019-04-22
00842180135932ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135949ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135956ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135963ELMEDELMED INCORPORATEDGCM2019-04-15
04055207011652NARichard Wolf GmbHGCM2017-07-21
04055207058015NARichard Wolf GmbHGCM2017-07-21
04055207058022NARichard Wolf GmbHGCM2017-07-21