FDA.report

Forceps - Magnifier

Primary DI
00766588420103
Brand
Forceps - Magnifier
Company
Certified Safety Manufacturing, Inc.
Model
R242-010
Catalog number
R242-010
Device description
Forceps - Magnifier
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTDFORCEPS

Product Code Classifications

CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K940249000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K940249000CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGCertified Safety Mfg., Inc.1994-10-03LRR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766588420103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588420103007665884201037665884201030766588420103

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts

PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags

DUNS number
788460483
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
false

Other Devices From This Company

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00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260051Burn Dressing Small - Red Velcro BagK626-005K626-0052026-03-23
00766588127675RR - UP Vehicle - 75 RefillKR612-067KR612-0672026-03-02
00766588249810Class B 21 ANSI Plus - RTB 5186K624-981K624-9812026-03-02
0076658825009050 Person Contractors Kit - 24 Poly WhiteK625-009K625-0092026-03-02
00766588235714607 QF Strips Plastic 1"x 3" 16/BoxR523-571R523-5712026-02-05
00766588235998QF C-Protector Mouth-to-Mouth BarrierR523-599R523-5992026-02-05
00766588251035PG&E Field Class B 21 Plus - Jump Bag 5210K625-103K625-1032026-02-05
00766588252070Snake Bite EconomyR525-207R525-2072026-02-05
00766588252087PG&E Expirables - ZLBR525-208R525-2082026-02-05
00766588260013Safety General PurposeK626-001K626-0012026-02-05
00766588250076Safety General Purpose - 10 Poly WhiteK625-007K625-0072025-12-18
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitR523-574R523-5742025-12-17
00766588120676RR - UP Facilities - 75VK612-067K612-0672025-12-15
00766588235721608 - Adhesive Bandages Plastic 2"x 3" - 6/unitR523-572R523-5722025-12-15
00766588160825816 - Nitrile Gloves - 2 pr/unitR216-082R216-0822025-12-08
00766588190051QF Tape 1/2" x 2.5 yds. - RollR519-005R519-0052025-12-08
00766588250083Safety General Purpose - 16 Poly WhiteK625-008K625-0082025-12-08
00766588069012Gillig Bus 24 - RefillKR606-301KR606-3012025-12-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10766588420100Forceps - Magnifier UDI/10Certified Safety Manufacturing, Inc.HTD2026-05-26
00810143907537SURGIPROSSurgipros, LLCHTD2026-05-23
00190776417994MillenniumAvalign Technologies, Inc.HTD2026-03-23
24026704941494PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
24026704941500PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
00192896122857Diamond Head Grasping ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-19
00810158219267PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219274PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219045PRINCETONPrinceton Medical Group, Inc.HTD2026-03-11
00192896122741Micro Alligator ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
00192896122758Brophy Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
B382S1350010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382050Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382060Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382100Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382110Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S9057001000Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901132120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901186250Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD90118621C0Surgical DirectSurgical Direct, Inc.HTD2026-02-26
G4250605120My MedicalMy Medical Store LLCHTD2026-02-26