FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403465666
Brand
Snowden-Pencer
Company
CAREFUSION 2200, INC
Model
RL3330-30
Catalog number
RL3330-30
Device description
Snowden-Pencer MIS RIGID LAPAROSCOPE, 2.9MM 300MM, 30 DEGREE
Published
2017-12-05
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

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
10885403465666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540346566610885403465666

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850081334033Zenflow Spring® ScopeZENFLOW, INC.FAJ2026-05-22
00850081334057Zenflow Camera Control UnitZENFLOW, INC.FAJ2026-05-22
00848657023122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657023139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657068956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069236AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069243AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069250AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069618AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657074889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075060AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075084AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075244AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075725AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076289AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076692AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078160AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078177AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078184AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078191AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086936AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086943AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00810116023431Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-01-22
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