FDA.reportPublic FDA data

PurCel Labs Safety Lancets Push-Button (30G x 1.5mm)

Primary DI
00810143550146
Brand
PurCel Labs Safety Lancets Push-Button (30G x 1.5mm)
Company
Purcel Labs LLC
Model
1100-100
Device description
LANCET, PUSH-BTN SFTY, AUTO RETRACT, 30G NDL 1.5MM, FIXED DEPTH, LIGHT GREEN (100/BX)
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222090000Safety LancetNingbo Medsun Medical Co., Ltd.2022-09-30FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143550146PackageGS120In Commercial Distribution
00810143550139PrimaryGS10
10810143550136Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143550146008101435501468101435501460810143550146
00810143550139008101435501398101435501390810143550139
1081014355013610810143550136

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
127672531
Device count
100
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143550221PurCel Labs Small Vinyl Exam Gloves1200-1502023-08-04
00810143550252PurCel Labs Medium Vinyl Exam Gloves1201-1502023-08-04
00810143550283PurCel Labs Large Vinyl Exam Gloves1202-1502023-08-04
00810143550313PurCel Labs XL Vinyl Exam Gloves1203-1502023-08-04
00810143550573PurCel Labs Small 4 MIL Black Exam Gloves1400-1002023-08-15
00810143550603PurCel Labs Medium 4 MIL Black Exam Gloves1401-1002023-08-15
00810143550634PurCel Labs Large 4 MIL Black Exam Gloves1402-1002023-08-15
00810143550665PurCel Labs XL 4 MIL Black Exam Gloves1403-1002023-08-15
00810143550771PurCel Labs ASTM Level 1 Surgical Masks3000-502023-08-18
00810143550795PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks3001-502023-08-18
00810143550405 PurCel Labs Safety Insulin Pen Needles (32G x 4mm)1086-1002023-08-08
00810143550429 PurCel Labs Safety Insulin Pen Needles (31G x 5mm)1087-1002023-08-08
00810143550443PurCel Labs Safety Insulin Pen Needles (30G x 6mm)1088-1002023-08-08
10810143550402 PurCel Labs Safety Insulin Pen Needles (32G x 4mm)1086-1002023-08-08
00810143550481 PurCel Labs Safety Insulin Pen Needles (31G x 5mm)1087-1002023-08-08
00810143550504PurCel Labs Safety Insulin Pen Needles (30G x 6mm)1088-1002023-08-08
00810143550788PurCel Labs ASTM Level 1 Surgical Masks3000-502023-08-18
00810143550801PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks3001-502023-08-18
00810143550580PurCel Labs Small 4 MIL Black Exam Gloves1400-1002023-08-15
00810143550610PurCel Labs Medium 4 MIL Black Exam Gloves1401-1002023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
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08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
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08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20