FDA.reportPublic FDA data

PrimeSight

Primary DI
04250480106488
Brand
PrimeSight
Company
SCHÖLLY FIBEROPTIC GmbH
Model
08-4206
Device description
Hysteroscope/Cystoscope 4 x 302 mm, 12°
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250480106488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250480106488042504801064884250480106488

GMDN Terms#

Term, Definition table
TermDefinition
Rigid cystoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999info@schoelly-usa.com

Regulatory Flags#

DUNS number
316276682
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
true
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
04250480104200NA95-39092025-06-11
04250480104262N/A05-0762nir2025-06-11
04250480103906NA41-0005a2025-04-09
04250480100271NA05.0100z2025-01-15
04250480100288NA05.0101o2025-01-15
04250480100295NA05.0102b2025-01-15
04250480100325NA05.0106c2025-01-15
04250480100349NA05.0108z2025-01-15
04250480100356NA05.0110b2025-01-15
04250480100363NA05.0112c2025-01-15
04250480101759NARL-1002025-01-15
04250480101766NARL-1302025-01-15
04250480101773NARL-1452025-01-15
04250480101780NARL-5002025-01-15
04250480101797NARL-5302025-01-15
04250480101704NAVP-7000X2024-12-03
04250480101711NASC-7000X2024-12-03
04250480101728NALG-7000X2024-12-03
04250480101735NAAL-7000X 2024-12-03
04250480112809NA05.0085l.ht2024-01-08

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Primary DI, Brand, Company table
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00848657068956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069236AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069243AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
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00848657069618AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
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00848657075084AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
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00848657086943AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
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06971176281729EviewZhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
06971176281965EviewZhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
06971176283570Foot Switch (HRF-M5 PS)Zhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
00848657076845AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
00848657077040AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
00848657078061AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
06972520302893Ascend™ Single-Use Flexible Cysto-Nephroscope HDGuangzhou Red Pine Medical Instrument Co., Ltd.FAJ2025-12-31